Description/职位描述:
SECTION 1: JOB SUMMARY*
·020202020202 Perform various technical duties of quality control and quality
assurance such as: Establish quality procedures and test method for raw
materials, in-process and finish good.
·020202020202 Perform quality control and quality assurance for product transfer and
BWI Carto product manufacturing process.
·020202020202 Work scope covers BWI Carto product in Ethicon Suzhou site.
SECTION 2: DUTIES & RESPONSIBILITIES*
Under and in accordance with all applicable federal, state and local
laws/regulations and Corporate Johnson & Johnson, procedures and guidelines,
this position:
o0202 Establish and maintain appropriate documentation as required for Quality
Assurance activities and the Quality Documentation Systems.
o0202 Maintain and improve incoming, in-process quality control, finish good
release procedure, provide technical support of process validations and risk
management control.
o0202 Draft quality procedures and test method for raw materials, in-process and
finish good.
o0202 Responsible for inspection instrument qualification and test method
validation.
o0202 Provide Quality support in Product transfers and new products development.
o0202 Perform investigation of NC, CAPA, complaint investigation as needed;
o0202 Review NCR and disposition of nonconforming products.
o0202 Assist in training of production and inspectors on quality knowledge.
o0202 Participate in process/quality improvement projects.
o0202 Support COGs initiatives.
o0202 Responsible for following and administering safety.
o0202 Compliance with safety policies and procedures.
o0202 Follow J &J and Ethicon Records Management Policies for Convenience
information, Records Retention Schedules, Training and Education, Document Hold
Notices, Records Cleanout, Inactive Records and Information Management, Vital
Records and the third-party vendor if applicable.
o0202 Provide as needed, subject matter expert feedback on manufacturing process
changes.
o0202 Responsible for communicating business related issues or opportunities to
next management level.
o0202 Responsible for ensuring personal and Company compliance with all Federal,
State, local and Company regulations, policies, and procedures.
o0202 Performs other duties assigned as needed.
Qualifications/任职要求:
SECTION 3: EXPERIENCE AND EDUCATION*
·020202020202 Bachelor's degree and above in chemical, mechanical or pharm preferred.
·020202020202 3-5 years related work experience or demonstrated performance.
·020202020202 Experience in electrical, medical device and pharm industry.
02
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and
AFFILIATIONS*
·020202020202 Six Sigma Green Belt preferred.
·020202020202 Fluent in oral English is preferred.
·020202020202 GMP/ ISO knowledge preferred.
·020202020202 Good communication skill and teamwork spirit.